Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Russian Science Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Patients with depression (target number - 60) receive resveratrol 500 mg or placebo (1:1) each morning daily for 1 month with primary outcome measures of the score change on depression rating scale HDRS-17 and change in SIRT1 activity in the blood measured 4 times over the study period (before, in the middle, after the intervention, and in 2 week follow up).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resveratrol Pill | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol Pill | Drug | Resveratrol 500 mg |
| |
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total HDRS-17 Score From Baseline to Week 4 | Hamilton Depression Rating Scale 17 items, total score range 0-53 (53 - worse) | 4 weeks |
| Change in SIRT1 Activity From Baseline to Week 4 | SIRT1 is enzyme sirtuin-1 which activity is measured in the blood | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total BDI-II Score From Baseline to Week 4 | Beck Depression Inventory 21 items, total score range 0-63 (63 - worse) | 4 weeks |
Not provided
Inclusion Criteria (selectively):
Exclusion Criteria (selectively):
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyubomir I. Aftanas | Novosibirsk | 630117 | Russia |
Eight enrolled patients dropped out during the 5-day run-in inpatient-study period
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Resveratrol Pill | Resveratrol Pill: Resveratrol 500 mg |
| FG001 | Placebo | Placebos: Placebo Pills |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Resveratrol Pill | Resveratrol Pill: Resveratrol 500 mg |
| BG001 | Placebo | Placebos: Placebo Pills |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Total HDRS-17 Score From Baseline to Week 4 | Hamilton Depression Rating Scale 17 items, total score range 0-53 (53 - worse) | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
6 weeks
UKU Side-Effect Rating Scale was used in all 4 visits to collect adverse event information
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resveratrol Pill | Resveratrol Pill: Resveratrol 500 mg | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lyubomir Aftanas | Institute of Physiology and Basic Medicine | +7-913-912-2228 | liaftanas@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2018 | Oct 16, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo Pills |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Major depressive disorder (MDD) type | recurrent / single / persistent MDD, according to the DSM-5 classification | Count of Participants | Participants |
|
| Winter season | Number of participants enrolled/treated in the dark half of the year | Number | participants |
|
|
|
| Primary | Change in SIRT1 Activity From Baseline to Week 4 | SIRT1 is enzyme sirtuin-1 which activity is measured in the blood | Posted | Mean | Standard Deviation | units | 4 weeks |
|
|
|
| Secondary | Change in Total BDI-II Score From Baseline to Week 4 | Beck Depression Inventory 21 items, total score range 0-63 (63 - worse) | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Placebo | Placebos: Placebo Pills | 0 | 11 | 0 | 11 | 0 | 11 |
Not provided
Not provided
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| persistent |
|